Nov 2023 Invited Talk for in-depth review of ICH E9. MFDS-Industry statistics workshop
Aug 2023 Invited Talk for propensity score analysis in real-world data (MFDS)
April 2023 Invited Talk for flexible parametric model and piecewise model in HIRA (Health Insurance Review and Assessment Service)
Mar 2023 Invited Talk for statistical issues in clinical trials (MFDS)
Nov 2022. Invited Talk for in-depth review of ICH E9. MFDS-Industry statistics workshop
Oct 2022. Invited Talk in MFDS for statistical significance
Sep 2022 Invited Talk in MFDS for statistical analysis of dissolution comparison when f2 cannot be used
May 2022 Invited Talk in MFDS for add-on study in bioequivalence
April 2022 Invited Talk in MFDS for Bayesian clinical trials in the development of orphan drugs
Feb 2022 Invited Talk in MFDS for statistical issues in bioequivalence studies.
Feb 2021 Invited Talk in MFDS for Adaptive Designs.
Sep 2019. Invited Talk in the Ministry of Food and Drug Safety. “Can real world data prove efficacy of a new drug?”
Aug 2019. Invited Talk in the sixth symposium of the International Society of Biopharmaceutical Statistics. “Effects on between-batch variability on the type I error rate in the biosimilar development”
Dec 2018. Invited Talk in the Korean Society of Pharmaceutical Medicine. "Multiple testing in clinical trials"
June 2019. Moderator of Biostatisticians’ meeting to promote biopharmaceutical industry in Global Bio Conference.
June 2018. Invited Talk in the Korea Japanese Pharmaceutical Association. “Statistical Issues in Multi-Regional Clinical Trials”
June 2018. Moderator of Biostatisticians’ meeting to promote biopharmaceutical industry in Global Bio Conference.
June 2018. Invited Talk in the Korea Research-based Pharmeutical Industry Association. “Statistical Issues in Multi-Regional Clinical Trials”
April 2018. Invited Talk in the Ministry of Food and Drug Safety. “Statistical Issues in the development of rare disease”
Nov 2017. Invited Talk in the Biostatistics forum sponsored by the Ministry of Food and Drug Safety. “Statistical Issues in MRCT”
Nov 2017. Invited Talk in Annual Meeting of Korean Statistical Society. “Avoiding ambiguity of type I error rates in non-inferiority trials”
Sep 2017. Invited Talk in Samsung Bioepis. “The Comparison of Three Measures for Evaluating Biosimilarity Binary Endpoints”
June 2017. Invited Talk in Global Bio Conference. “Usage of Non-Inferiority Design: Points to Consider from Regulatory Agency and Pharmaceutical Companies.”
Feb 2017. Invited Talk in the Ministry of Food and Drug Safety. “FDA guideline of Enrichment Strategies in Clinical Trials”
Dec 2016. Invited Talk in the International Chinese Statistical Association Conference. “Statistical Implications of Extrapolating the Overall Result to the Target Region in Multi-Regional Clinical Trials”
June 2016. Invited Talk in Samsung Bioepis. "Statistical issues in the design of experiments"
June 2016. Moderator of Biostatisticians’ meeting to promote biopharmaceutical industry in Global Bio Conference.
Dec 2015. Invited Talk in the Far-East Regional Biometric Conference. “New perspective of Japanese sample size calculation method in MRCT”
July 2015. Invited Talk in Meeting of International Society of Biopharmaceutical Statistics for “Regional type II error rate for testing the consistency of treatment effect across regions in MRCT”
Dec 2014. Invited Talk in Taiwan National Health Research Institute for “Avoiding Ambiguity of Type I Error Rates in Non- Inferiority Trials”
June 2014. Invited Talk in the Annual Meeting of the Chinese Institute of Probability and Statistics
Aug 2013. Invited Talk in Joint Meeting of the IASC satellite conference for the 59th ISI WSC
May 2013. Invited Talk in Korea Food and Drug Administration. “Multiple Testing in Clinical Trials”
October 2012. Invited Talk in Korea Food and Drug Administration for “Statistical Issues in Non-Inferiority Trials”
April 2012. Invited Talk in Korea Food and Drug Administration for “Statistical Issues in the development of Biosimilar Products”
February 2012. Invited Talk in Center for Devices and Radiological Health (U.S.FDA). “Strength of Evidence of Non-Inferiority Trials”
Sep 2011. Invited Talk in University of Maryland at Baltimore County for “Strength of evidence of non-inferiority trials”
May 2010. Invited Talk inKorea Food and Drug Administration for “Issues in adaptive designs”
July 2009. Invited Talk in the Center for Drug Evaluation and Research (U.S. FDA). “Impact of violation of constancy assumptions in non-inferiority trials”
July 2009. Invited Talk in Eli Lilly for “Impact of violation of constancy assumptions in non-inferiority trials”
Dec 2008. Invited Talk in Statistical Computation and Visualization
June 2008. Invited Talk in the annual meeting of Japanese biostatistics society
Feb 2008. Invited Talk in the 2nd international Krume symposium on biostatistics
Jan 2008. Invited Talk in Tokyo University of Science
Jan 2008. Invited Talk in Japan National Institute of Public Health
Nov 2007. Invited Talk in the Korean Statistical Association. “Test of Homogeneity of Two Binomial Proportions in
Extremely Unbalanced 2 x 2 Contingency Tables”
Dec 2006. Invited Talk in the Korea Food and Drug Administration. “Statistical Methods in New Drug Development”
Nov 2006. Invited Talk in Krume University in Japan
Oct 2005. Invited Talk in the Korean Statistical Association. “The Size of the Chi-square Test for the Hardy-Weinberg Law”
Mar 2004. Invited Talk in the Assay Validation Symposium, Seoul, Korea. “Statistical Methods in Assay Validation”
Apr 2003. Invited Talk in the Korean Pharmaceutical Society Meeting. “On Sample Size Calculations in Bioequivalence Trials”
Nov 2002. Invited Talk in the Korea Food and Drug Administration. “Statistical Methods in Microbial Risk Assessment”
Jul 2002. Invited Talk in the International Symposium on Bioequivalence and Strategy for Drug Research and Development. “Statistical Methods in Bioequivalence Tests”
Apr 2000. Invited Talk in the ENAR, Chicago, USA. “Incorporating Model Uncertainties along with Data Uncertainties in Microbial Risk Assessment”
Aug 1999. Invited Talk in the ASA, Baltimore, USA. “An Approximate Unconditional Exact Test for Non-Inferiority”